BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    P.T.H. METAL-BACKED ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Endotracheal tube; Reinforced Endotracheal tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 12, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 6, 2010

    PENUMBRA SYSTEM SEPARATOR 3MAX

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·December 12, 2012

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024